510(k) · Cleared
ClearedSensimatic 500SE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parkell, Inc. · EKZ Unit, Electrosurgical, And Accessories, Dental
Cleared on Jun 6, 1995 after a 137-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1,329 later devices descend from it.
- Decided
- Jun 6, 1995
- Review
- 137 days
- Class
- Class II
- Product code
- EKZ
- Recalls
- None
- Predicates
- 0
1,329 later devices descend from it, 2 citing it directly.
- This deviceK950239 Sensimatic 500SEParkell, Inc. · 1995
- Descendant · cites it directly · 1,325 of its ownK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- Descendant · 2 generations on · 1,322 of its ownK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- Descendant · 2 generations on · 1,219 of its ownK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- Descendant · 3 generations on · 1,073 of its ownK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- Descendant · 4 generations on · 1,069 of its ownK000944 Thermage Thermacool SystemThermage, Inc. · 2000
Showing 5 of 1,329 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,329 · See all- K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996 · cites it directly1,325descendants
- K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997 · 2 generations on1,322descendants
- K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998 · 2 generations on1,219descendants
- K981870Visage Cosmetic Surgery SystemArthrocare Corp. · 1998 · 3 generations on1,073descendants
- K000944Thermage Thermacool SystemThermage, Inc. · 2000 · 4 generations on1,069descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950239 | Sensimatic 500SE | Parkell, Inc. | 1995 | — |
| +1 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| +2 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| +2 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| +3 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| +4 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 14 | 0 |
| 2003 | 24 | 0 |
| 2004 | 16 | 0 |
| 2005 | 22 | 0 |
| 2006 | 18 | 0 |
| 2007 | 21 | 0 |
| 2008 | 44 | 0 |
| 2009 | 31 | 0 |
| 2010 | 40 | 0 |
| 2011 | 28 | 0 |
| 2012 | 35 | 0 |
| 2013 | 47 | 0 |
| 2014 | 48 | 0 |
| 2015 | 56 | 0 |
| 2016 | 73 | 0 |
| 2017 | 70 | 0 |
| 2018 | 59 | 0 |
| 2019 | 49 | 0 |
| 2020 | 62 | 0 |
| 2021 | 68 | 0 |
| 2022 | 85 | 0 |
| 2023 | 81 | 0 |
| 2024 | 101 | 0 |
| 2025 | 136 | 0 |
| 2026 | 84 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EKZ device
- #1 K213477 Root ZX3score 5.3 · 6 generations · no Class I recall
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (1,329)
See all 1,3292 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K962445 (Arthrocare Corp., 1996) has gone furthest, with 1,325 descendants of its own.
How does its category compare?
All EKZ devicesEKZ Unit, Electrosurgical, And Accessories, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EKZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · EKZ
Too few EKZ 510(k)s in any year since 2007 to give a median.
Recalls per year · EKZ
No recall names EKZ since 2007.
Adverse event reports per year · EKZ
6in 2018
MAUDE reports naming product code EKZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K950239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950239: Sensimatic 500SE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950239
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026